Panels › Orthopedic › Product code KWQ · Class 2
Appliance, Fixation, Spinal Intervertebral Body
Regulation 888.3060
11510(k)s in 12 months (668 all time)
1recalls in 12 months (214 all time)
165recalls that name a 510(k)
Top companies in KWQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Spine | 6 | 38 |
| Alphatec Spine, Inc. | 9 | 32 |
| RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | 0 | 41 |
| Zimmer, Inc. | 1 | 37 |
| Medtronic Sofamor Danek | 29 | 8 |
| Nuvasive, Inc. | 21 | 0 |
| K2m | 20 | 0 |
| Depuy Spine, Inc. | 10 | 8 |
| Blackstone Medical, Inc. | 13 | 3 |
| Globus Medical, Inc. | 15 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 4, 2020 | K200883 | CarboClear® Cervical Plate System CarboFix Orthopedics , Ltd., IL | KWQ |
| May 28, 2020 | K200885 | Meridian Anterior Plate System, Regatta Lateral Plate System SeaSpine Orthopedics Corporation | KWQ |
| May 21, 2020 | K200995 | Insignia Anterior Cervical Plate System Alphatec Spine, Inc. | KWQ |
| May 21, 2020 | K200956 | NuVasive Thoracolumbar Plates Nu Vasive, Incorporated | KWQ |
| May 20, 2020 | K201078 | NuVasive® ACP System Nu Vasive, Incorporated | KWQ |
| May 12, 2020 | K201136 | Cure Lumbar Plate System Meditech Spine, LLC | KWQ |
| May 5, 2020 | K200846 | Balteum Lumbar Plate System Huvexel Co. , Ltd., KR | KWQ |
| Apr 30, 2020 | K200523 | Biolign® Roto-Loc Cervical Plate System Elite Surgical Supplies (Pty), Ltd., ZA | KWQ |
| Apr 6, 2020 | K193494 | Origin Anterior Cervical Plate System Orthopaedic & Spine Development, FR | KWQ |
| Mar 24, 2020 | K200224 | SEA-LINK Anterior Cervical Plate System Indius Medical Technologies Pvt. , Ltd., IN | KWQ |
| Feb 5, 2020 | K200170 | SpineNet SSP System Spinenet, LLC | KWQ |
| Nov 20, 2019 | K192792 | TranS1 AxiaLIF Plus System Trans1 | KWQ |
| Nov 8, 2019 | K192049 | Oryx Cervical Plate System Innovasis, Inc. | KWQ |
| Oct 29, 2019 | K192494 | NexGen Anterior Cervical Plate System Precision Spine | KWQ |
| Oct 24, 2019 | K192678 | Genesys Spine Binary® Lumbar Plate System Genesys Spine | KWQ |
| Oct 23, 2019 | K192314 | RESONATE Anterior Cervical Plate System Globus Medical, Inc. | KWQ |
| Oct 22, 2019 | K191584 | FORTICO Anterior Cervical Fixation System Camber Spine Technologies, LLC | KWQ |
| Sep 3, 2019 | K191500 | NuVasive® ACP System Nu Vasive, Incorporated | KWQ |
| Aug 30, 2019 | K191786 | Cyclops Anterior Cervical Plate System Degen Medical, Inc. | KWQ |
| Aug 29, 2019 | K192076 | Binary® Anterior Cervical Plate System Genesys Spine | KWQ |
| Jun 12, 2019 | K190016 | Lateral Plate System Corelink, LLC | KWQ |
| May 31, 2019 | K190565 | Cervical Plate Eisertech, LLC | KWQ |
| May 29, 2019 | K183084 | Fuji Cervical Plate System Altus Partners, LLC | KWQ |
| May 15, 2019 | K190584 | CAYMAN LP Plate System K2m, Inc. | KWQ |
| May 13, 2019 | K190170 | MVP Cervical Plate System GS Medical Co., Ltd., KR | KWQ |
| May 9, 2019 | K190666 | CYGNUS Anterior Cervical Plate System MiRus, LLC | KWQ |
| May 1, 2019 | K190227 | Boomerang Anterior Cervical Plate System Choicespine, LP | KWQ |
| Apr 19, 2019 | K183056 | ASSURE® Anterior Cervical Plate System Globus Medical, Inc. | KWQ |
| Mar 21, 2019 | K190425 | CastleLoc-P Anterior Cervical Plate System L&K BIOMED Co., Ltd., KR | KWQ |
| Feb 11, 2019 | K183409 | Athena II Cervical Plate System Medyssey USA, Inc. | KWQ |
| Feb 11, 2019 | K183073 | SMG Anterior Cervical Plate System Sapphire Medical Group | KWQ |
| Feb 6, 2019 | K182885 | Atlantis Anterior Cervical Plate, Divergence Anterior Cervical Fusion System, Premier Anterior Cervical Plate, Ventur Medtronic Sofamor Danek USA, Inc. | KWQ |
| Feb 1, 2019 | K190053 | SECULOK ACP System U&I Corporation, KR | KWQ |
| Jan 17, 2019 | K183060 | CervAlign Anterior Cervical Plate System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | KWQ |
| Jan 17, 2019 | K181190 | Pinehurst Anterior Cervical Plate System Signature Orthopaedics Pty, Ltd., AU | KWQ |
| Jan 16, 2019 | K182489 | 4CIS® Pinehurst Anterior Cervical Plate system Solco Biomedical Co., Ltd., KR | KWQ |
| Jan 3, 2019 | K183214 | Raven Lumbar Plate System Choicespine, LP | KWQ |
| Dec 17, 2018 | K180772 | Met One Czar Anterior Cervical Plate System Met One Technologies | KWQ |
| Dec 12, 2018 | K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and K2m, Inc. | KWQ |
| Nov 29, 2018 | K182418 | V3 Segmental Plating System Atlas Spine, Inc. | KWQ |
| Nov 9, 2018 | K182808 | Aspida® Anterior Lumbar Plating System Alphatec Spine, Inc. | KWQ |
| Nov 6, 2018 | K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XT Globus Medical, Inc. | KWQ |
| Sep 10, 2018 | K182055 | SECULOK ACP System U&I Corporation, KR | KWQ |
| Aug 31, 2018 | K181543 | Cure OPEL-C Plate System Meditech Spine, LLC | KWQ |
| Aug 3, 2018 | K181549 | Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) Curiteva, LLC | KWQ |
| Aug 2, 2018 | K181562 | Curiteva Anterior Cervical Plate System Curiteva, LLC | KWQ |
| Jul 20, 2018 | K180022 | Athena Cervical Plate System Medyssey USA, Inc. | KWQ |
| Jul 13, 2018 | K181063 | Kestrel Buttress Plate System Innovasis, Inc. | KWQ |
| Jul 10, 2018 | K181244 | Zavation Cervical Plate System Zavation Medical Products, LLC | KWQ |
| Jul 6, 2018 | K180755 | Vail ALIF Buttress Plate System Evolution Spine, LLC | KWQ |
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